TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
TULIP
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of TA-8995 in Patients With Mild Dyslipidaemia, Alone and In Combination With Statin Therapy
2 other identifiers
interventional
364
2 countries
17
Brief Summary
The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein cholesterol (LDL-C), alone and in combination with statin therapy. The secondary objectives of this study are to determine the safety and tolerability of TA-8995 in patients with mild dyslipidaemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2013
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 21, 2014
August 1, 2014
11 months
October 21, 2013
August 20, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.
12 weeks
Study Arms (9)
Group 1
PLACEBO COMPARATORTA-8995 0mg (placebo) \& placebo statin
Group 2
EXPERIMENTALTA-8995 1mg \& placebo statin
Group 3
EXPERIMENTALTA-8995 2.5mg \& placebo statin
Group 4
EXPERIMENTALTA-8995 5mg \& placebo statin
Group 5
EXPERIMENTALTA-8995 10mg \& placebo statin
Group 6
ACTIVE COMPARATORTA-8995 0mg (placebo) \& atorvastatin 20mg
Group 7
ACTIVE COMPARATORTA-8995 10mg \& atorvastatin 20mg
Group 8
ACTIVE COMPARATORTA-8995 0mg (placebo) \& rosuvastatin 10mg
Group 9
ACTIVE COMPARATORTA-8995 10mg \& rosuvastatin 10mg
Interventions
Eligibility Criteria
You may qualify if:
- Fasting LDL-C levels \>2.5 mmol/L and \<4.5 mmol/L, HDL-C levels \<1.8 mmol/L and \>0.8 mmol/L, and TG levels \<4.5 mmol/L after run in or washout of existing therapies
- Not on lipid-altering therapy at screening or on lipid-altering treatment regimens at screening
You may not qualify if:
- Body mass index \>32 kg/m2;
- Participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (Visit 2);
- Any clinical manifestation of atherosclerotic vascular disease;
- Diagnosis of type 1 diabetes;
- Uncontrolled type 2 diabetes: haemoglobin A1c \>8%;
- Uncontrolled hypertension: sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>90 mmHg;
- History of hyperaldosteronism;
- Active muscle disease or persistent creatine kinase concentration \>3 Ă— the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xention Ltdlead
Study Sites (17)
H:S Amager Hospital
Copenhagen, Denmark
Sydvestjysk Sygehus
Esbjerg, Denmark
Herlev University Hospital
Herlev, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Regionshopitalet - Silkeborg
Silkeborg, Denmark
EB FlevoResearch B.V
Almere Stad, Netherlands
Andromed Amsterdam
Amsterdam, Netherlands
Andromed Leiden
Amsterdam, Netherlands
Academic Medical Centre
Amsterdam-Zuidoost, Netherlands
Andromed Breda B.V
Breda, Netherlands
Andromed Eindhoven
Eindhoven, Netherlands
Andromed Noord B.V
Groningen, Netherlands
Andromed Zoetermeer
Leiderdorp, Netherlands
Andromed Rotterdam BV
Rotterdam, Netherlands
Albert Schweitzer Ziekenhuis
Sliedrecht, Netherlands
Andromed Oost
Velp, Netherlands
Praktijk Zwijndrecht
Zwijndrecht, Netherlands
Related Publications (3)
Martin SS, Ditmarsch M, Simmons M, Alp N, Turner T, Davidson MH, Kastelein JJP. Comparison of low-density lipoprotein cholesterol equations in patients with dyslipidaemia receiving cholesterol ester transfer protein inhibition. Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):148-155. doi: 10.1093/ehjcvp/pvac056.
PMID: 36307922DERIVEDvan Capelleveen JC, Kastelein JJ, Zwinderman AH, van Deventer SJ, Collins HL, Adelman SJ, Round P, Ford J, Rader DJ, Hovingh GK. Effects of the cholesteryl ester transfer protein inhibitor, TA-8995, on cholesterol efflux capacity and high-density lipoprotein particle subclasses. J Clin Lipidol. 2016 Sep-Oct;10(5):1137-1144.e3. doi: 10.1016/j.jacl.2016.06.006. Epub 2016 Jun 25.
PMID: 27678430DERIVEDHovingh GK, Kastelein JJ, van Deventer SJ, Round P, Ford J, Saleheen D, Rader DJ, Brewer HB, Barter PJ. Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2015 Aug 1;386(9992):452-60. doi: 10.1016/S0140-6736(15)60158-1. Epub 2015 Jun 2.
PMID: 26047975DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 28, 2013
Study Start
August 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 21, 2014
Record last verified: 2014-08